Evaluation of Levemir® for the Treatment of Type 1 and 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00655044

Purpose

This study is conducted in Europe.

The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using Levemir® under normal clinical practice conditions.

Condition	Intervention
Diabetes Mellitus	Drug: insulin detemir

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin Detemir

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control
Official Title:	Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 1 or Type 2 Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1C [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3945
Study Start Date:	May 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A Type 1 and type 2 diabetes patients	Drug: insulin detemir Safety and effectiveness data collection in connection with the use of drug Levemir in daily clinical practice.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Type 1 and type 2 diabetes patients

Criteria

Inclusion Criteria:

Type 1 diabetes
Type 2 diabetes
Candidates of use of a basal insulin as part of their diabetes regimen

Exclusion Criteria:

Unwilling to adhere to therapy or follow up
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655044

Locations

Russian Federation

Moscow, Russian Federation, 119330

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Akeel Ballan, RN/MSc/BAcom

Novo Nordisk Russia

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-3514
Study First Received:	April 4, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00655044
Health Authority:	Russia: Federal Service for Control of Health Care and Social Developme

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009